Tenaculum for use with occlusion devices

ABSTRACT

Devices, systems and methods for grasping, manipulating and retaining tissue are provided. In different aspects, devices, systems and methods for locating tissue; for guiding instruments to tissue; for grasping tissue; and for retaining and manipulating tissue are provided. Such tissue may include the cervix of a female patient. A device may have a distal portion having a sound configured to enter a cervical os without causing undue trauma or discomfort to the patient, and a retention element such as a spike configured to engage and retain a patient&#39;s cervix. Devices may include a proximal portion, such as a handle. Devices may be configured to co-operate with other instruments. Cooperation with other instruments may include serving as a mount for instruments and guiding instruments. Such devices may aid in the placement and operation of instruments for therapeutic and diagnostic procedures, such as, for example, treating uterine disorders and conditions.

FIELD OF THE INVENTION

[0001] The invention relates generally to the field of devices and methods for holding and manipulating body tissue. In particular, the invention is directed to devices and methods for holding and manipulating the cervix and uterus of a female patient.

BACKGROUND OF THE INVENTION

[0002] It is often desirable to hold, maneuver, and retain tissue during medical procedures. Devices for gripping, holding, and manipulating tissue are thus often very useful during medical procedures, particularly ones involving tissues, organs, and structures that are relatively inaccessible or otherwise difficult to reach or to retain.

[0003] In many medical procedures, it is useful to locate the cervix and cervical os of a female patient. For example, location of the cervical os and cervix is necessary for proper positioning for the performance of a dilatation and curettage procedure. In order to perform a hysterectomy, particularly with a transvaginal approach, it is often useful to grasp the cervix. This may aid in orienting the uterus, in reducing unwanted motion of the uterus during a procedure, or to manipulate the uterus into a favorable position during treatment. Devices and methods for grasping, retaining and manipulating a uterus may be useful in many other medical procedures as well.

[0004] Hysterectomy (surgical removal of the uterus) is performed on approximately 800,000 women annually in the United States. Hysterectomy is often the therapeutic choice for the treatment of uterine cancer, adenomyosis, menorrhagia, uterine prolapse, dysfunctional uterine bleeding (abnormal menstrual bleeding that has no discrete anatomic explanation such as a tumor or growth), and muscular tumors of the uterus, known as leimyoma or uterine fibroids.

[0005] However, hysterectomy is a drastic treatment, entailing the removal of the uterus and the resulting loss of reproductive function. Thus, any method which can approximate the therapeutic result of a hysterectomy without removing the uterus would be a significant improvement in this field. Newer treatment methods have been developed for some diseases which may spare these women a hysterectomy.

[0006] In 1995, it was demonstrated that uterine fibroids could be treated without hysterectomy using a non-surgical therapy, specifically comprising bilateral intraluminal occlusion of the uterine arteries (Ravina et al., “Arterial Embolization to Treat Uterine Myomata”, Lancet Sept. 9, 1995; Vol. 344; pp. 671-692, incorporated in its entirety herein). This technique is known as “uterine artery embolization”. In this technique, uterine arteries are accessed via a transvascular route from a common femoral artery into the left and right uterine arteries.

[0007] The uterus has a dual (or redundant) blood supply, the primary blood supply being from the bilateral uterine arteries, and the secondary blood supply from the bilateral ovarian arteries. Consequently, when both uterine arteries are occluded, i.e. bilateral vessel occlusion, the uterus and the fibroids contained within the uterus are both deprived of their blood supply. However, as demonstrated by Ravina et al., the effect on the fibroid is greater than the effect on the uterus. In most instances, the fibroid withers and ceases to cause clinical symptoms. See also Burbank, et al., “Uterine Artery Occlusion by Embolization or Surgery for the Treatment of Fibroids: A Unifying Hypothesis—Transient Uterine Ischemia,” The Journal of the American Association of Gynecologic Laparoscopists, November 2000, Vol. 7, No.4 Supplement, pp. S3-S49. U.S. Pat. No. 6,254,801, to Burbank et al., entitled “Methods for Occlusion of the Uterine Arteries,” describes numerous devices and methods useful for occluding a uterine artery by penetrating the tissue of the patient to access the uterine artery.

[0008] However, catheter-based uterine artery embolization under radiologic direction requires specialized equipment and sophisticated procedures. Accordingly, far fewer uterine artery embolizations than hysterectomies are performed for uterine fibroids which are symptomatic.

[0009] What is needed, therefore, are devices and methods to locate, retain and manipulate the cervix, uterus and related tissues and structures that can be used by physicians of ordinary skill in a simple medical setting or environment to aid in therapeutic procedures.

SUMMARY OF THE INVENTION

[0010] The invention is directed to devices and methods for locating, retaining, and manipulating a cervix and uterus and related tissues and structures of a female human patient. Thus, in one embodiment, the invention provides devices for locating a cervix and a cervical os comprising an elongated shaft having a distal portion configured for entry into a cervical os. The elongated shaft has a proximal portion, which may include a handle and may be detachable from the distal portion. A gripping mechanism configured for engaging a cervix and/or a uterus may be operatively connected to the elongated shaft effective to retain the device in a desired location adjacent the cervix. A guide rail may also be connected to the proximal portion of the elongated shaft. The elongated shaft distal portion preferably has a rounded tip, and may comprise a soft material, or a malleable material, or both. In further embodiments, at least a portion of the guide rail may be configured to cooperate with other instruments. For example, in some embodiments, the guide rail is configured to receive a cylindrical connector, rounded sleeve, or other attachment element attached to another instrument effective to allow the tenaculum to work cooperatively with the other instrument.

[0011] A tenaculum having features of the invention may be used to guide, stabilize, anchor, or otherwise control the relationship between body tissue and another instrument. A tenaculum having features of the invention may be configured to grasp and hold onto the cervix of a female patient to, for example, aid in placement and retention of uterine artery occlusion devices. A tenaculum having features of the invention may be configured to function cooperatively with other devices to provide occlusion of the uterine arteries. Such a tenaculum may provide guidance for the placement and use of other devices, such as uterine artery occlusion devices, including providing guidance along centerline of the cervix. A tenaculum having features of the invention may provide a locking feature effective to maintain the axial position relative to the cervix of a device such as a uterine artery occlusion device. A tenaculum having features of the invention may include detachable portions, so that a distal portion configured to be completely contained within the vagina, cervix and uterus may be deployable while attached to a cervix, providing greater mobility and comfort to a patient during treatment.

[0012] In further embodiments, the invention provides methods for gripping a cervix, comprising inserting into a cervical os a sound of a tenaculum having an elongated shaft having a distal portion configured for entry into a cervical os and a proximal portion, a handle operatively connected to said proximal portion of said elongated shaft, a gripping mechanism operatively connected to said elongated shaft and configured for engaging a cervix effective to retain said device in a desired location adjacent said cervix, and a guide rail connected to said proximal portion of said elongated shaft, and engaging said cervix with said gripping mechanism.

[0013] The methods further comprise methods for manipulating a cervix and uterus, comprising inserting into a cervical os and/or uterine canal a sound of a tenaculum having an elongated shaft having a distal portion configured for entry into a cervical os and a proximal portion, a handle operatively connected to said proximal portion of said elongated shaft, a gripping mechanism operatively connected to said elongated shaft and configured for engaging a cervix effective to retain said device in a desired location adjacent said cervix, and a guide rail connected to said proximal portion of said elongated shaft; engaging said cervix with said gripping mechanism; and manipulating said handle portion so as to maneuver and/or retain said cervix and uterus into and/or in a desired position.

[0014] The devices, systems and methods embodying features of the invention thus provide tools and methods to aid in the treatment of diseases and conditions that may require grasping and retaining a cervix and uterus. Devices and methods having features of the invention may be used to provide improved treatments for serious conditions and diseases, including uterine fibroids, adenomyosis, dysfunctional uterine bleeding (DUB), postpartum hemorrhage, and other uterine disorders. The devices and methods are simple and easy to use, simple to remove, and thus provide many advantages over other methods and devices for treating such conditions and diseases.

BRIEF DESCRIPTION OF THE DRAWINGS

[0015]FIG. 1A is a perspective view of an angled tenaculum embodying features of the invention.

[0016]FIG. 1B is a perspective view of a linear tenaculum embodying features of the invention with the retention element in a disengaged configuration.

[0017]FIG. 1C is a longitudinal cross-sectional view of the deployable linear tenaculum illustrated in FIG. 1B taken along line 1C-1C.

[0018]FIG. 2A is a perspective view of a linear tenaculum embodying features of the invention with the retention element in an engaged configuration.

[0019]FIG. 2B is a transverse cross-sectional view of the linear tenaculum illustrated in FIG. 2A taken along line 2B-2B.

[0020]FIG. 3A is a perspective view of a deployable angled tenaculum embodying features of the invention after separation of a distal portion from proximal handle portions.

[0021]FIG. 3B is a perspective view of a deployable linear tenaculum embodying features of the invention after separation of a distal portion from a proximal portion.

[0022]FIG. 4A illustrates an angled tenaculum having features of the invention assembled with a medical instrument.

[0023]FIG. 4B illustrates a linear tenaculum having features of the invention assembled with a medical instrument.

[0024]FIG. 5 is a schematic diagram of a reproductive system of a human female illustrating the placement of a tenaculum embodying features of the invention partially into the cervical os within the vagina of a female human patient.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0025] The invention provides systems 10, devices and methods for gripping and manipulating tissue. A tenaculum 12 embodying features of the invention may be used alone to grip and manipulate tissue, or with other devices as part of a system 10 to provide a stable foundation for, e.g., the occlusion of uterine arteries in a female patient. A tenaculum 12 embodying features of the invention is suitable for gripping a cervix, uterus, or other related structure of a female patient, and for manipulating the position of cervix, uterus, or other related structure of a female patient. Embodiments of tenacula 12 suitable for use in a system 10 having features of the invention include an angled tenaculum 12 embodying features of the invention, as shown in FIG. 1A and a linear tenaculum 12 embodying features of the invention, as shown in FIGS. 1B and 1C. It will be understood that tenaculum features and elements discussed with respect to an angled tenaculum 12 may also apply to a linear tenaculum 12 as well, and that tenaculum features and elements discussed with respect to a linear tenaculum 12 may also apply to an angled tenaculum 12.

[0026] As shown in FIG. 1, a tenaculum 12 has a tenaculum shaft 14 that may be connected with handle or handles 16. Shaft 14 has a distal portion comprising a tenaculum sound 18 with a distal tip 20. A sound 18 is preferably malleable or flexible, and may be resilient. Flexibility and malleability are useful, for example, in order to accommodate a patient's anatomy, including the orientation and disposition of a patient's cervix and cervical os. A sound 18, and a distal tip 20 are preferably configured to contact tissue without causing undue trauma or discomfort to a female patient. A configuration that does not cause undue trauma or discomfort, and tissue contact without undue trauma or discomfort, may be termed “atraumatic”; entry of such a device or element within a cervical os may be termed “atraumatic entry.” For example, a distal tip 20 is preferably rounded in order to reduce the possibility of trauma to the cervix and to reduce possible discomfort to the patient as sound 18 is introduced into a cervix via a cervical os, enabling a tenaculum 12 to provide a structure for guiding subsequent placement of another device or devices of a system 10. In addition, a sound 18 and distal tip 20 may be sized, angled, finished, coated, or otherwise configured to reduce possible trauma and discomfort during use.

[0027] A tenaculum 12 may be secured in place by application of a retention element such as tenaculum spike 22 into tissue so as to retain a tenaculum 12 in place. A retention element such as spike 22 or spikes 22 may be disposed on an engagement arm 24 and configured to move into place so as to hold tissue. A spike 22 may be disposed so as to engage tissue, for example, when a tenaculum 12 is in place with a sound 18 within a cervical os, by movement of engagement arm 24 so as to place a spike 22 into tissue adjacent sound 18. Thus, for example, closure of tenaculum handles 16 of an angled tenaculum 12 (e.g., by pressing tenaculum handles 16 closer together), rotating engagement arm 24 around pivot 26 is effective to move spike 22 towards sound 18, and is effective to press spike 22 into tissue in a tissue-engaging configuration. A spike 22 pressed into cervical tissue is effective to retain a tenaculum 12 in place within a patient's vagina when sound 18 is in place within a cervical os of a patient. A tenaculum 12 may include multiple spikes 22. It will be understood that other retention elements configured to retain a tenaculum 12 in place within or on a patient's body, such as serrations, grooves, or other elements, may be used with or in place of a spike 22. A retention element such as a spike 22 may be held in a tissue-engaging configuration by a lock mechanism 28, such as a ratchet shown in FIG. 1A.

[0028] A spike 22, or other retention element, allows an operator to manipulate a patient's tissue with a tenaculum 12 by, for example, pulling on a handle 16 when spike 22 is engaged with tissue so that the tissue follows the movement of the tenaculum 12. Such manipulation of a patient's tissue may be desirable to place the tissue in a desired position or orientation; for example, pulling on a cervix extends the cervix and stretches adjacent tissue, such as the vaginal formix, and pulls the uterine arteries towards the vagina so that these arteries become stretched and compressed between vaginal formix and uterus so as to occlude, or to facilitate the occlusion of, the uterine arteries. A tenaculum 12 embodying features of the invention may be used with devices and methods for occlusion of uterine arteries, including occlusion devices with pressure-applying members. For example, occlusion devices may be guided by, may mount on, may be retained by, and may be stabilized by a tenaculum 12.

[0029] A shaft 14 of an angled tenaculum 12 may include a guide rail 30 disposed proximal to sound 18. A guide rail 30 may have a smooth outer surface or may have threads 32 on at least a portion of its length. A sound 18 and guide rail 30 are preferably collinear, and may comprise parts or ends of a single shaft 14.

[0030] A locking tube 34 may be attached to, or mounted on, a guide rail 30. A locking tube 34 may be configured to engage a guide rail 30 by having a distal collar portion 36 (which preferably has a bore with internal threads) that is configured to engage threads 32 of a guide rail 30. A locking tube 34 may also have a proximal portion 38, which may be configured as a handle for manipulation by an operator, connected to the distal collar portion 36 by a connecting portion 40. In preferred embodiments, a connecting portion 40 is flexible; for example, a connecting portion 40 may be a piece of flexible tubing sized to tightly engage the distal 36 and proximal 38 portions of a locking tube 34.

[0031] An angled tenaculum 12 embodying features of the invention may have a pair of handles 16, or may have a handle 16 comprising only a single handle portion. A linear tenaculum 12 typically has a single handle portion 16. A linear tenaculum 12 may have a shaft 14 including a distal portion 42 and a proximal portion 44. Sound 18 with distal tip 20 is typically collinear with shaft 14 of a linear tenaculum 12. A handle 16 may be attached to a proximal portion 44 of a linear tenaculum 12; alternatively, a proximal portion 44 may serve as a handle 16 when held by an operator. In either case, a shaft 14 of a linear tenaculum 12, or portions thereof, may serve as a guide rail 30.

[0032] A linear tenaculum 12 having features of the invention may comprise multiple shafts or tube assembled together to form a shaft 14. For example, as illustrated in FIG. 1C, a shaft 14 of a linear tenaculum 12 may comprise a bolt 46 having bolt threads 48 on at least a distal portion, a proximal body tube 50 and a distal body tube 52 having inner threads 54 complementary to bolt threads 48. A proximal body tube 50 may be configured to engage a distal body tube 52 by, for example, having a distal end 56 comprising a lip 58 with a stop 60. The lip 58 of a proximal body tube 50 may be configured to accept a portion of a distal body tube 52, and the stop 60 may be configured to regulate the length of distal body tube 52 held within lip 58. An outer tube 62 may be disposed around proximal body tube 50 and configured to move longitudinally along shaft 14.

[0033] A retention element such as a spike 22 of linear tenaculum 12 is disposed on an engagement arm 24 which may be connected to shaft 14 at a joint 64. In preferred embodiments, a joint 64 is a fixed point of attachment between engagement arm 24 and shaft 14; movement of retention element such as spike 22 towards shaft 14 is enabled by the flexibility of at least a portion of engagement arm 24. Alternatively, joint 64 may comprise a pivot, a spring, a flexible sleeve, or other form of flexible attachment mechanism to join engagement arm 24 with shaft 14. Closure of engagement arm 24, effective to move spike 22 near to shaft 14 and sound 18 for engagement with tissue, may be effected, for example, by distal movement of handle 16, causing distal movement of a closure element such as a closure sleeve 66 disposed about shaft 14 so as to press on joint 64 so as to move spike 22 towards shaft 14. A linear tenaculum 12, as illustrated in FIGS. 1 and 2 provides the advantage of a much lower profile than, for example, an angled tenaculum 12 as illustrated in FIG. 1. A lower profile may be advantageous during use within a patient's vagina, for example, in that it leaves more room around the device for other instruments, for observation, and may be more comfortable for the patient than other designs.

[0034] An engagement arm 24 (carrying a spike 22) is preferably a flexible arm, and is preferably fixedly joined to shaft 14 at a joint 64. As illustrated in the Figures, joint 64 may be a depression, such as a “D”-shaped slot in a round shaft 14, into which a complementarily-shaped end 68 of engagement arm 24 is fitted. End 68 may be welded, pinned, glued, or otherwise fixedly attached to shaft 14. An engagement arm 24 may be made with metal, such as stainless steel, or other durable, flexible material, including polymers. Alternatively, a joint 64 may include a spring, or a hinged joint, or both.

[0035] A spike 22 disposed on portions of engagement arm 24 may be moved closer to shaft 14 by pressure effective to flex engagement arm towards shaft 14 effective to place it in a tissue-engaging configuration. For example, a closure sleeve 66 may be disposed around shaft 14, preferably outside proximal body tube 50 and configured to move (e.g., slide) longitudinally along proximal body tube 50. In embodiments of the invention, an outer tube 62 may have a distal end configured to engage a closure sleeve 66 effective to cause it to move longitudinally along proximal body tube 50.

[0036] A closure sleeve 66 held in place by a closure pin 70, pressing on an engagement arm 24 is effective to close and retain engagement arm 24 in a closed configuration. An engagement arm 24 having a spike 22 disposed in such a closed configuration and in contact with tissue is effective to grip tissue and to retain a tenaculum 12 in place engaged with the tissue.

[0037] A closure sleeve 66 may be locked into place so as to maintain a spike 22 in a tissue-engaging configuration. A closure sleeve 66 may have a locking slot 72 configured to accept a closure pin 70. For example, a closure pin 70 attached to shaft 14 may be lodged within a locking slot 72 so as to hold a closure sleeve 66 in a configuration that contacts engagement arm 24 so as to place a spike 22 into a tissue-engaging configuration. A closure pin 70 is preferably disposed on distal shaft portion 42, preferably on distal body tube 52. Preferably, a locking slot 72 has a non-linear shape, including, for example, a bend such as a right-angled bend, so that a locking slot 72 has a longitudinal portion disposed along a longitudinal axis and a latitudinal portion disposed at an angle (e.g., at a right angle) to a longitudinal axis. A non-linear slot is effective to retain a closure pin 70 and constrain a closure sleeve 66 from further longitudinal motion after lodgment of closure pin 70 within locking slot 72. Such lodgment may be obtained, for example, by longitudinal movement of closure sleeve 66 so as to bring a closure pin 70 within a longitudinal portion of a locking slot 72, followed by rotational movement of closure sleeve 66 so as to place closure pin 70 within a latitudinal portion of the locking slot 72.

[0038] A closure sleeve 66 may be moved into place by distal movement of an outer body tube 62 disposed around proximal body tube 50. A distal portion 74 of outer body tube 62 is preferably configured to engage with a proximal portion 76 of a closure sleeve 66 so as to transmit both longitudinal and rotational motion from the outer body tube 62 to the closure sleeve 66. For example, a distal portion 74 may have a step or steps configured to engage a complementary step or steps of a proximal portion 76 as illustrated in FIGS. 1 and 2, effective to allow rotation of an outer body tube 62 to be transferred to a closure sleeve 66. As discussed above, such rotational motion of closure sleeve may be effective to lodge a closure pin 70 within a locking slot 72.

[0039] A tenaculum having features of the invention may be configured for disassembly during use, resulting in separate distal and proximal portions, so as to leave a distal portion engaged with tissue while allowing removal of a proximal portion. Removal of a proximal portion provides another means for providing greater comfort and freedom of movement to a patient receiving treatment. A tenaculum configured for disassembly during use may be termed a “deployable tenaculum.” For example, an angled tenaculum 12 as illustrated in FIG. 3A may have detachable handles 16 configured for detachment from, and re-attachment to, a distal portion of angled tenaculum 12 that includes pivot 26, engagement arm 24, spike 22, and sound 18. The detachable distal portion may thus be deployed while engaged with tissue, and remain engaged with tissue, after detachment of handles 16. Handles 16 may be re-attached at a later time if desired, and may, for example, aid in removal of the distal portion from the patient's tissue.

[0040] In embodiments of tenacula having features of the invention, a linear tenaculum 12 may be configured to disassemble into a separate distal portion 42 and a separate proximal portion 44. Such separation allows the removal of proximal portion 44 from within a patient's body while distal portion 42 remains in place during use. As illustrated in FIG. 3B, a spike 22 and engagement arm 24 may be retained in a tissue-engaging configuration after deployment of the distal portion 42 by locking a closure sleeve 66 into place with a closure pin 70 lodged within locking slot 72.

[0041]FIG. 3B provides a perspective view of a deployable linear tenaculum 12, including a distal portion 42 and a proximal portion 44 of a disassembled deployable linear tenaculum 12. Portions 42 and 44 of a linear tenaculum 12 may be held together by a bolt 46, with a portion of distal body tube 52 held within a lip 58. Alternatively, a distal portion 42 of shaft 14 may be attached with a proximal portion 44 of shaft 14 by a lip 58 and distal body tube 52 having complementary threads configured to form a threaded attachment. Thus, for example, distal portion 42 may be attached to proximal portion 44 by screwing the portions together, and distal portion 42 may be detached from proximal portion 44 by unscrewing the portions.

[0042] Thus, a deployable linear tenaculum may have a sound 18 for entry into the cervical os, a shaft 14 for manipulating and controlling the cervix, a spike 22 for grasping the cervix disposed on an engagement arm 24, a mechanism to open and close the spike 22 (such as a joint 64 configured to be operated by closure sleeve 66 disposed around shaft 14), and a mechanism to deploy the distal portion 42 (such as by unscrewing bolt 46). An advantage of a tenaculum 12 having a deployable distal portion 42 over other configurations of tenacula 12 having features of the invention is that the deployed distal portion 42 may be fully contained within the vagina and uterus of the patient during use after deployment. The deployable distal portion 42 may serve as a guide and/or as a base or mounting element for the use with other instruments.

[0043] Systems 10 including an angled tenaculum 12 and a linear tenaculum 12 engaged with other instruments are illustrated in FIGS. 4A and 4B respectively. Other instruments suitable for use with a tenaculum 12 having features of the invention include clamps and constrictors configured for applying pressure to tissue, such as a cervix or uterus of a female patient. Although it will be understood that many devices are suitable for use in a system 10 with a tenaculum 12 having features of the invention, one example of such an instrument is an occlusion device 80 with pressure-applying elements 82 as illustrated in FIGS. 4A and 4B. A system 10 including an angled tenaculum 12 and a device 80 is illustrated in FIG. 4A; a system 10 including a linear tenaculum 12 and a device 80 is illustrated in FIG. 4B. Occlusion devices with pressure-applying elements are disclosed in co-pending U.S. patent applications “Occlusion Device with Deployable Paddles for Detection and Occlusion of Blood Vessels” by Fred H. Burbank et al., assigned to Vascular Control Systems Inc., and “Deployable Constrictor for Uterine Artery Occlusion,” by Fred H. Burbank et al., assigned to Vascular Control Systems Inc., both applications filed on the same day as the present application, and both hereby incorporated by reference in their entirety.

[0044] A device 80 may be operatively connected with a tenaculum by an attachment sleeve 84, which may be configured to at least partially surround or enclose a portion of guide rail 30. An attachment sleeve 84 may be configured to engage a guide rail 30 effective that an attachment sleeve 84 may slide longitudinally along the guide rail 30. An attachment sleeve 84 is preferably configured to slide along portions of a guide rail 30 having a smooth outer surface and to slide along portions of a guide rail 30 having threads 32. Such sliding movement of an attachment sleeve 84 carries device 80 along the path defined by guide rail 30 of tenaculum 12. Thus, engagement of an attachment sleeve 84 with a guide rail 30 is effective to guide and direct the movement of a device 80 by a tenaculum 12. Where locking tube 34 is not moved, or where it is locked into a position, such engagement between an attachment sleeve 84 of a device 80 is effective to immobilize and retain device 80 with respect to a tenaculum 12.

[0045] A tenaculum 12 may engage a patient's tissue; thus, where a device 80 is engaged with a tenaculum 12, the positioning and movement of a device 80 relative to a patient's tissue may be guided and directed by a tenaculum 12. For example, the advancement of a locking tube 34 effective to press distal collar portion 36 of locking tube 34 against attachment sleeve 84 is effective to advance attachment sleeve 84 distally, and thereby also moving device 80 and pressure-applying elements 82 in a distal direction. Advancement of an outer tube 62 distally along a shaft 14 of a linear tenaculum 12 is similarly effective to advance an attachment sleeve 84 distally, and thereby to move a device 80 and pressure-applying elements 82 in a distal direction. Such distal movement may be useful, for example, to advance a device 80 towards a cervix where a device 80 is mounted on a tenaculum 12 is engaged with cervical tissue.

[0046] A schematic diagram of female human reproductive anatomy and related structures is shown in FIG. 5, illustrating the placement and use therein of a tenaculum 12 embodying features of the invention. The anatomical features shown in FIG. 5 include uterus 90, vagina 92, cervix 94, vaginal formix 96, cervical os 98, and uterine arteries 100 (which provide a large fraction of the uterine blood supply). A uterine fibroid 102 is also illustrated. As discussed above, and as disclosed in U.S. application Ser. No. 09/908,815, filed Jul. 20, 2001, to Burbank et al. (“'815 application”), co-assigned with the present application, the entire contents of which are incorporated by reference herein, reduction or abolition of blood flow in the uterine arteries 100 is effective to treat uterine fibroids 102 and other disease conditions of the uterus 90 and female reproductive organs. An angled tenaculum 12 may be useful in such treatments, by, for example, guiding clamps or other instruments configured to occlude a uterine artery 100 into position within a patient's vagina 92, cervix 94, and/or uterus 90, and by, for example, serving as a guide to aid in the placement of an instrument and/or by providing a platform for stabilizing or holding such instruments in place during their use. Although a linear tenaculum 12 is shown in FIG. 5, it will be understood that an angled tenaculum 12 as illustrated in FIG. 1, and other tenacula embodying features of the invention may also be placed and used therein in a similar manner.

[0047] In order to engage a tenaculum 12 with cervical tissue, distal tip 20 of a tenaculum sound 18 may be inserted without trauma into the cervical os 98, providing a structure for guiding subsequent placement of a device 80 of a system 10. Placement of a distal tip 20 of a sound 18 within a patient's cervix 94 serves to locate the angled tenaculum 12 in a position effective to guide the placement of pressure-applying elements 82 onto and around a cervix 94 so as to aid in the location and occlusion of uterine arteries 100 of a female patient. Pressure-applying elements 82 may be configured to release from a proximal portion of a device 80, while retaining a secure attachment between pressure-applying elements 82 and a tenaculum 12 even after the release of pressure-applying elements 82 from the rest of device 80.

[0048] A device 80 may be attached to a tenaculum 12 before placement of a tenaculum within a patient's vagina 92, for example, or may be attached at a later time, such as after a tenaculum 12 has been engaged with a patient's tissue. The secure engagement between tenaculum 12 and a cervix 94 may be used to pull, or otherwise maneuver, the cervix 94 as needed by the operator. For example, pulling on cervix 94 may be useful to place uterine arteries 100 into closer apposition to the vaginal formix 96 or uterus 90, or both, and so to aid in subsequent compression of these arteries by a device 80 attached to a tenaculum 12.

[0049] Rotation of locking tube 34 so that threads 32 engaged with internal threads of locking tube 34 advance locking tube 34 may be effective to advance a locking tube 34. Such advancement places distal collar portion 36 of locking tube 34 in contact with attachment sleeve 84, pushing attachment sleeve 84 and connected device 80 in a distal direction. Such movement is effective to advance a device 80 towards target tissue when a system 10 is in place with a tenaculum 12 engaged with a patient's tissue. Such movement may be useful in methods for occluding uterine arteries 100. For example, where a device 80 comprises a clamp with pressure-applying elements 82 configured to apply pressure to a cervix 94 or uterus 90, such advancement is effective to place pressure-applying elements 82 in a suitable position within a female patient's vagina 92 so as to allow application of pressure-applying elements 82 for occlusion of the patient's uterine arteries 100.

[0050] A uterus 90 may be accessed via a vagina 92 and cervix 94. A vagina 92 has a wall extending to form the vaginal formix 96 adjacent cervix 94. Cervix 94 may be approached by medical instruments such as a tenaculum 12 as illustrated in FIG. 5, and/or a system 10 including an angled tenaculum 12 having features of the invention. Cervical os 98, located at the apex of the cervix 94, provides an opening into the uterus 90. The uterus 90 is supplied with blood by the uterine arteries 100 and the ovarian arteries; it is believed that, in most women, the uterine arteries 100 provide the more significant fraction of the uterine blood supply. Thus, a major portion of the blood supply to the uterus 90 derives from the uterine arteries 100 which branch off the iliac arteries, and a smaller but often still significant portion of the uterine blood supply derives from the ovarian arteries which branch directly from the aorta.

[0051] The uterine arteries 100 of female humans are typically disposed about 3 cm or less from the vaginal wall near the vaginal formix 96 where a uterine artery 100 meets the uterus 90, although this distance between a uterine artery 100 and the uterus 90 may vary between patients. The cervix 94 can be used as a platform and a landmark from which to locate and access a uterine artery 100. In addition, the uterus 90, a muscular and generally firm mass, can be used as a backstop or anvil against which a uterine artery 100 can be compressed.

[0052]FIG. 5 illustrates a linear tenaculum 12 in use and configured to grasp a cervix 94 of a female patient. The sound 18 is inserted into the cervical os 98 and the spike 22 is closed onto the cervix 94 to establish traction and hold on the cervix 94. The spike 22 can be used on different portions of a cervix 94, including on either the anterior or posterior lip of the cervix. Engagement of a spike 22 with tissue allows an operator to pull on or otherwise manipulate a patient's tissue with a tenaculum 12. Such manipulation of a patient's tissue may be desirable to place the tissue in a desired position or orientation; for example, pulling on a cervix 94 extends the cervix 94 so as to provide a better configuration for placement of paddles 14 and for occlusion of uterine arteries. Pulling on a cervix 94 also stretches uterine arteries 100, placing them closer to uterus 90 and in a favorable position for their occlusion by compression between vaginal formix 96 and uterus 90. Lodgment of a closure pin 70 within a locking slot 72 in a closure sleeve 66 is effective to maintain engagement arm 24 and spike 22 of a linear tenaculum 12 in position so as to maintain the tissue configuration for as long as desired. Similarly, a ratchet 28 configured to lock handles 16 of an angled tenaculum 12 into a closed configuration is effective to maintain engagement arm 24 and spike 22 in position so as to maintain the tissue configuration for as long as desired.

[0053] A deployable tenaculum 12 has a distal end 42 configured to engage and retain a cervix 94, and a proximal end 44 which may have a handle 16. The distal end 42 may be detached from the proximal end 44, so as to remain engaged with a cervix 94 while detached from the proximal end 44. During attachment and use, before detachment of the proximal 44 (handle) portion from the distal 42 (tissue-engaging) portion, at least part of the proximal portion 44 (e.g., a handle portion 16) may extend out from a patient's vagina, available to an operator. Where the linear tenaculum 12 is a deployable tenaculum, the distal 42 and proximal 44 portions may be disassembled after attachment of spike 22 with the cervix 94. With the distal portion 42 of the linear tenaculum 12 firmly grasping the cervix 94, the proximal portion 44 of the linear tenaculum 12 can then be removed from vagina 92, leaving only the distal deployable portion 42 attached to the cervix 94 and within the vagina 92. By removing the portion of the device that extends outside her body, detachment of the proximal portion 44 from the distal portion 42 allows greater comfort and freedom of movement to a patient during a procedure.

[0054] The proximal portion 44 of the device 12 can be set aside and later used to retrieve the deployable distal portion 42 at the end of the procedure (e.g., after uterine artery occlusion has been achieved and maintained for a therapeutically effective time period). The ability to detachable a distal portion 42 allows for minimal bulk and discomfort within the vagina 92 relative to a non-deployable tenaculum 12, and provides better visual access to an attending physician during a procedure following deployment. Thus, a deployable tenaculum having features of the invention is useful in any procedure requiring a tenaculum 12 where patient comfort or increased visual field are desired.

[0055] A tenaculum 12 may be used to pull, stretch, and otherwise manipulate a cervix to aid in the application and use of a device 80. For example, a device 80 may comprise a constrictor, such as a resilient form made of wire or other material configured to contact and to compress a cervix 94. Deployment of such a device 80 may be aided by use of a tenaculum 12 to engage a cervix 94. For example, an angled tenaculum 12 may be used to manipulate the cervix 94, to reposition it or to apply tension to it during initial placement of a device 80. A tenaculum 12 may be used to guide a delivery shaft carrying a device 80 within the vagina 92 so as to aid in the placement of a device 80 onto the cervix 94, and to aid in the positioning of the device 80 for the duration of the occlusion of uterine arteries 100.

[0056] In embodiments of devices having features of the invention, a tenaculum sound 18 may be between about 1 inch and about 5 inches, preferably between about 1.5 inches and about 2.5 inches in length. A guide rail 30 may be between about 1 inch and about 12 inches long, and is preferably between about 3 inches and about 6 inches in length. In preferred embodiments of devices embodying features of the invention, a guide rail 30 may be between about 0.125 inches and about 0.25 inches in diameter. Handles 16 of an angled tenaculum 12 may lie generally along a line making an angle with a guide rail 30, or may form an angle bisected by such a line, where the angle may be between about 10° and about 30°, preferably between about 15° and about 20°.

[0057] A sound 18 and distal tip 20 may be made, at least in part, with materials such as silver, silver alloys, or other biocompatible materials. A sound 18 made at least in part with a silver or silver alloy, or of other biocompatible materials, may be flexible and or malleable, so that a clinician may readily adjust the tip to conform to the anatomy and clinical presentation of an individual patient if desired.

[0058] In embodiments of devices having features of the invention, an engagement arm 24 may have a length of between about 1 and about 4 inches, preferably between about 2 to about 3 inches.

[0059] Tenacula having features of the invention may be made from any suitable biocompatible, sterilizable material or combination of materials including stainless steel, shape memory alloys such as nickel titanium alloys, biocompatible and sterilizable thermoplastic and thermoset materials such as for example, polycarbonate, polyesters, modified polyurethanes, polyphenylene oxide, polysulfone, polyethylene, polyacetal, and other polymers and other biocompatible and preferably sterilizable metals, plastics, ceramics, and other materials suitable for making medical instruments known in the art. Devices and systems may be designed for single use (disposable) or may be sterilizable and capable of being used multiple times.

[0060] While particular forms of the invention have been illustrated and described, it will be apparent that various modifications can be made without departing from the spirit and scope of the invention. Accordingly, it is not intended that the invention be limited to the specific embodiments illustrated. It is therefore intended that this invention to be defined by the scope of the appended claims as broadly as the prior art will permit, and in view of the specification if need be. Moreover, those skilled in the art will recognize that features shown in one embodiment may be utilized in other embodiments. Terms such a “element”, “member”, “device”, “sections”, “portion”, “section”, “steps” and words of similar import when used herein shall not be construed as invoking the provisions of 35 U.S.C. §112(6) unless the following claims expressly use the terms “means” or “step” followed by a particular function without specific structure or action. All patents and patent applications referred to above are hereby incorporated by reference in their entirety. 

What is claimed is:
 1. A hand-held device for use with medical instruments and for manipulating tissue of a female patient having a cervix and a cervical os, comprising: an elongated shaft with a proximal portion and a distal portion defining a longitudinal direction along a longitudinal axis, said distal portion having a distal tip configured for atraumatic entry into said cervical os; a tissue retention element operatively attached to said elongated shaft and configured to grip tissue when said shaft distal tip is disposed within said cervical os; and a guide rail portion of said device configured to engage a medical instrument.
 2. The tissue manipulating device of claim 1, wherein said elongated shaft distal tip comprises a rounded tip.
 3. The tissue manipulating device of claim 1, wherein said distal portion of said elongated shaft comprises a malleable material.
 4. The tissue manipulating device of claim 3, wherein said malleable material comprises a soft metal.
 5. The tissue manipulating device of claim 4, wherein said soft metal comprises silver.
 6. The tissue manipulating device of claim 1, wherein said tissue retention element comprises an elongated arm, and wherein said operative attachment comprises a flexible connection between said elongated arm and said elongated shaft.
 7. The tissue manipulating device of claim 6, further comprising a closure element configured to press said elongated arm towards said elongated shaft.
 8. The tissue manipulating device of claim 7, wherein said closure element is configured to move longitudinally along said elongated shaft effective to press said elongated arm towards said elongated shaft.
 9. The tissue manipulating device of claim 6, wherein said elongated arm comprises a flexible portion, and said operative attachment comprises a fixed attachment between said elongated arm and said elongated shaft.
 10. The tissue manipulating device of claim 6, wherein said operative attachment comprises a pivot.
 11. The tissue manipulating device of claim 1, further comprising a securing element configured to secure said retention element so as to maintain the retention element in contact with tissue when said distal tip is disposed within said cervical os.
 12. The tissue manipulating device of claim 1, wherein said retention element comprises a sharp point.
 13. The tissue manipulation device of claim 6, wherein said guide rail portion is configured to receive a slidable coupling element attached to a medical device, said slidable coupling element being configured to move in a longitudinal direction along said guide rail portion effective to guide the motion of said medical device.
 14. The tissue manipulating device of claim 6, further comprising a collar configured to move in a longitudinal direction along said guide rail portion.
 15. The tissue manipulating device of claim 14, wherein said guide rail portion and said collar each comprise complementary threads configured to operatively engage with each other effective that engagement of said threads and rotation of said collar around said longitudinal axis is effective to provide longitudinal movement of said collar along said guide rail portion.
 16. The tissue manipulating device of claim 15, wherein said collar is configured to contact said slidable coupling element effective that longitudinal movement of said collar towards said slidable coupling element when said collar is in contact with said slidable coupling element is effective to effect longitudinal movement of said slidable coupling element.
 17. The tissue manipulating device of claim 1, further comprising a handle.
 18. The tissue manipulating device of claim 17, wherein said handle comprises two pivotally-connected portions configured for engagement by a human hand.
 19. The tissue manipulating device of claim 17, wherein said handle comprises a substantially cylindrical shaft.
 20. The tissue manipulating device of claim 19, wherein said handle comprises a proximal portion of said elongated shaft.
 21. The tissue manipulating device of claim 1, comprising a proximal portion and a distal portion, wherein said distal portion of said elongated shaft is configured to separate from said proximal portion of said device.
 22. The tissue manipulating device of claim 21, wherein said distal portion is configured to be retained in tissue when said portions are separated following engagement of said retention element with tissue.
 23. A system for manipulating tissue of a female patient having a cervix and a cervical os, comprising: a) a hand-held device for use with medical instruments and for manipulating tissue of a female patient having a cervix and a cervical os, comprising: an elongated shaft with a proximal portion and a distal portion defining a longitudinal direction along a longitudinal axis, said distal portion having a distal tip configured for atraumatic entry into said cervical os; a tissue retention element operatively attached to said elongated shaft and configured to grip tissue when said shaft distal tip is disposed within said cervical os; and a guide rail portion of said device configured to engage a medical instrument; and b) a medical instrument having a slidable coupling element configured to engage said guide rail portion of said device.
 24. The system for manipulating tissue of a female patient of claim 23, wherein said slidable coupling element is configured to move along said longitudinal direction.
 25. A hand-held device for use with a medical instrument and for manipulating tissue of a female patient having a cervix and a cervical os, comprising: a positioning means for atraumatic positioning of said device adjacent said cervical os; a tissue retention means configured to grip tissue; and a guide means configured to engage a medical instrument.
 26. The device of claim 1, wherein said distal portion having a distal tip configured for atraumatic entry into said cervical os comprises a length of between about 1 inch and about 5 inches.
 27. The device of claim 26, wherein said distal portion having a distal tip configured for atraumatic entry into said cervical os comprises a length of between about 1.5 inches and about 2.5 inches.
 28. The device of claim 1, wherein said guide rail comprises a length of between about 1 inch and about 12 inches.
 29. The device of claim 28, wherein said guide rail comprises a length of between about 3 inches and about 6 inches.
 30. The device of claim 1, wherein said guide rail comprises a diameter of between about 0.125 inch and about 0.25 inch.
 31. The device of claim 6, wherein said elongated arm comprises a length of between about 1 inch and about 4 inches.
 32. The device of claim 31, wherein said elongated arm comprises a length of between about 2 inches and about 3 inches. 